Dispenser with doses&#39; counter

ABSTRACT

There is provided a dispenser suitable for dispensing medicament, particularly medicament for use in the treatment of respiratory disorders. The dispenser comprises a housing having a support; a container, locatable within said housing, having an outlet, wherein said container dispenses through said outlet in response to movement of the container relative to the housing; and an actuation indicator having an indexing mechanism actuatable by movement of the container relative to the housing. A couple mechanism is provided which couples the indexing mechanism to the container to compensate for any variation in pre-actuation positionings of the indexing mechanism and container.

This application is a continuation of U.S. Ser. No. 10/224,000 flied anAug. 20, 2002, now issued U.S. Pat. No. 6,601,582, which is acontinuation of U.S. Ser. No. 09/445,658 filed on Mar. 31, 2000, nowissued U.S. Pat. No. 6,474,331, which was filed pursuant to 35 U.S.C.371 as a U.S. National Phase Application of International ApplicationNo. PCT/EP98/03379 filed on Jun. 8, 1998 claiming priority fromGB9711889.7 filed Jun. 10, 1997 and GB9721875.4 filed on Oct. 16, 1997.

The present invention relates to a dispenser having an actuationindicating device for indicating the number of actuations thereof. Inparticular, the invention relates to metered dose inhalers by means ofwhich medicaments contained in an aerosol container may be administeredto a patient.

It is well known to treat patients with medicaments contained in anaerosol, for example, in bronchodilator therapy. It is also known to usefor such therapy, medicaments which are contained in an aerosol and areadministered to a patient by means of an inhalation device comprising atubular housing or sleeve in which the aerosol container is located andan outlet tube leading out of the tubular housing. The aerosolcontainers used in such inhalation devices are designed to deliver apredetermined dose of medicament upon each actuation by means of anoutlet valve member at one end which can be opened either by depressingthe valve member while the container is held stationary or by depressingthe container while the valve member is held stationary. In the use ofsuch devices, the aerosol container is placed in the tubular housingwith the outlet valve member of the container communicating via asupport with the outlet tube, for example a nozzle or mouthpiece. Whenused for dispensing medicaments, for example in bronchodilation therapy,the housing is then held by the patient in a more or less uprightcondition and the mouthpiece or nozzle of the inhalation device isplaced in the mouth or nose of the patient. The aerosol container ispressed towards the support to dispense a dose of medicament from thecontainer which is then inhaled by the patient.

A problem arising from use of such known devices is that the patientcannot determine the amount of medicament in the container at any giventime. In an extreme case this could mean that the patient, possiblysuffering from severe bronchospasm and needing a dose of medicament,will find that the container will not dispense a dose because itscontents have already been exhausted.

In solution to the above described problem there has been suggested theuse of dose indicating devices, which typically count the number ofdoses delivered from or remaining in the aerosol container, therebyenabling the patient to determine how much medicament is available inthe container for future use. Typically, the dose indicating device hasan indexing (i.e. counting) mechanism actuated by movement of thecontainer relative to the housing, wherein a preset amount of relativemovement results in a count being indexed.

U.S. Pat. No. 4,817,822 describes an aerosol dispenser having a doseindicating device which, in a first embodiment is removably attached tothe end of the protruding portion of the aerosol container. Theoperating mechanism of the dose counter is located within a housingwhich extends from the end of the aerosol container along the externalsurface of the tubular housing.

U.S. Pat. No. 4,817,822 describes a dispenser having a dose indicatingdevice in which the operating mechanism of the dose indicating device islocated within a compartment in the housing and is actuated by means ofan actuator member attached to the aerosol container.

WO96/16686 describes an aerosol dispenser wherein the operatingmechanism of the dose indicating device is electronic and wherein theactuating member comprises a microswitch set into the wall of thehousing. The electronic counting mechanism and microswitch are containedwithin a hermetically sealed enclosure.

U.S. Pat. No. 5,482,030 describes an aerosol dispenser having amechanical dose indicator device located in and connected to the housingin the vicinity of the outlet tube of the aerosol container when fitted.

Many different pharmaceutical products are sold in the form of aerosolcontainers requiring different sized container bodies and/or valvesaccording to the required specifications. It is therefore normal forthere to be dimensional variations between different aerosol containers.Even between the same products there can be dimensional variations dueto manufacturing tolerances.

A problem which is common to all of the dose indicating devicesdiscussed above is that the indexing mechanism, which is actuated byrelative movement between the container body and housing, lacks anymeans of compensating for different pre-actuation positionings of theindexing mechanism relative to the container arising from, for example,dimensional variations between different aerosol containers. Hence, theindexing mechanisms must be dimensioned according to the product withwhich they are to be used, and so will not be interchangeable with otherproducts. Furthermore, in order for the indexing mechanism to record acount accurately, the dimensions of the components of any particulardevice must be manufactured to the required high tolerances.

The Applicants have now found that this problem can be ameliorated byuse of a coupling mechanism to compensate for the different relativepositions of the container and the indexing mechanism. The couplingmechanism acts such as to couple the container to the indexingmechanism. In one aspect, the coupling acts such as to couple theindexing mechanism to the rest position of the container. In another,clearly related aspect, the coupling mechanism acts such as to couplethe container to a start index (i.e. start count) position of theindexing mechanism.

According to one aspect of the present invention there is provided adispenser comprising a housing having a support; a container, insertablewithin said housing, having an outlet, wherein said container dispensesthrough said outlet in response to movement of the container relative tothe housing; and an actuation indicator having an indexing mechanismactuatable by movement from a rest position of the container relative tothe housing; and a coupling mechanism which acts such as to couple theindexing mechanism to said rest position.

Suitably, said coupling mechanism acts to position the indexingmechanism at a start index position when the container is at the restposition.

In one aspect, the coupling mechanism acts to position the indexingmechanism at a zero position on insertion of the container into saidhousing.

In another aspect, the coupling mechanism acts to position the indexingmechanism at a zero position in response to an initial (‘priming’)movement of the container from the rest position.

According to another aspect of the present invention there is provided adispenser comprising a housing having a support; a container, insertablewithin said housing, having an outlet, wherein said container dispensesthrough said outlet in response to movement of the container relative tothe housing; and an actuation indicator having an indexing mechanismactuatable from a start index position by movement of the containerrelative to the housing; and a coupling mechanism which acts such as tocouple the container to said start index position.

By use of a coupling mechanism it is possible to create an actuationindicator of one size which can be used in dispensers having valves andactuators made within a wide range of manufacturing tolerances and caneven fit a range of valves and actuators made to different dimensions.

Suitably, the indexing mechanism is actuatable by a predeterminedmovement of the container relative to the housing.

Suitably, the indexing mechanism indexes actuation by means of apredetermined rotary movement of a first member driven by movementrelative to a second member during actuation of the dispenser.Preferably, the second member remains stationary relative to the housingduring actuation of the dispenser.

In one preferred aspect, the first member comprises a pinion carried bya shaft through the coupling mechanism and the second member comprises arack.

In another preferred aspect, the first member comprises a yoke forengagement with the second member through the coupling mechanism.

Suitably, the coupling element comprises a friction drive mechanism.

Suitably, the container is an aerosol container.

Suitably, the container provides measured doses. Preferably, theactuation indicator indicates the number of doses dispensed from orremaining in the container.

Suitably, the dispenser herein comprises a housing having a support; acontainer, locatable within said housing, having an outlet member,wherein said container is movable relative to the housing to enabledispensing therefrom and said outlet member is connectable with saidsupport to prevent relative movement therebetween; and an actuationindicator, locatable within said housing. Preferably, the container andactuation indicator are reversably removable from the housing as asingle unit.

Suitably, the actuation indicator is engagable with the container in thevicinity of the outlet member. More preferably, the actuation indicatoris engagable with the outlet member.

Suitably, the actuation indicator is provided with a grip member whichis engagable with a neck portion of the container. Preferably, the neckportion is adjacent to or on the outlet member.

Suitably, the housing is provided with an outlet, more preferably in theform of a mouthpiece. Preferably, the dispenser comprises a passagethrough which dispensed doses may pass from the container to the outlet.

Suitably, the dispenser is a breath operated inhaler which is actuablein response to the inward breath of a user.

Preferably, the dispenser herein is an aerosol dispenser comprising ahousing in which a container is removably located, an outlet leadingfrom the housing and a support in the housing arranged to receive anoutlet member of the container and having a passage through which thecontents of the container may pass to the outlet, the outlet memberbeing held stationary in the housing support and the body of thecontainer being moveable relative to the outlet and housing to dispenseits contents in measured doses, and an actuation indicating devicehaving an actuation indicator for indicating the number of dosesdispensed from or remaining in the container. More preferably, theactuation indicating device is tightly connected to the container in thevicinity of the outlet member, such that the container and actuationindicating device may be removed from the housing as a single unit.

Preferably, the dispenser herein is a metered dose inhaler comprising ahousing in which the container is removably located, an outlet leadingfrom the housing, a support in the housing arranged to receive theoutlet member of the container and having a passage through which thecontents of the container may pass to the outlet, the outlet memberbeing held stationary in the housing support and the body of thecontainer being movable relative to the outlet and housing to dispenseits contents in measured doses, and a window through which the actuationindicator may be viewed.

A dispenser according to the invention will now be described withreference to the accompanying drawings in which:

FIG. 1 is a section through a standard inhalation device comprising anaerosol dispenser;

FIG. 2 is a section through the dose indicating device as fitted to anaerosol dispenser in an inhalation device;

FIG. 3 is a perspective view of a counting mechanism used in the doseindicating device of FIG. 2;

FIGS. 4 a, 4 b, 4 c, and 4 d show the sequence of operation of thecounter mechanism of FIG. 3;

FIGS. 5 a and 5 b show a lateral and a longitudinal section through asecond embodiment of the dose indicating device as fitted into thehousing of an inhalation device;

FIG. 6 shows an exploded view of a dose indicating device according to athird embodiment of the invention;

FIG. 7 shows another exploded view of the dose indicating device of FIG.6 together with an aerosol container and housing;

FIG. 8 shows a schematic section through an inhalation device comprisingthe dose indicating device of FIG. 6 in a rest position; and

FIG. 9 shows a schematic section through the inhalation device of FIG. 8in an actuated position.

A standard metered dose inhaler shown in FIG. 1 comprises a tubularhousing 1 in which an aerosol container 2 can be located. The housing isopen at one end (which will hereinafter be considered to be the top ofthe device for convenience of description) and is closed at the other.An outlet 3 leads laterally from the closed end of the housing 1. In theembodiment illustrated, the outlet 3 is in the form of a mouthpieceintended for insertion into the mouth of the patient but it may, ifdesired, be designed as a nozzle for insertion into the patient'snostril.

The aerosol container 2 has an outlet valve stem 4 at one end. Thisvalve member can be depressed to release a measured dose from theaerosol container or, alternatively, the valve stem 4 can be fixed andthe main body of the container can be moved relative to the valve memberto release the dose.

As shown clearly in FIG. 1, the aerosol container 2 is located in thehousing 1 so that one end protrudes from its open top. Spacer ribs (notshown) may be provided inside the housing to hold the external surfaceof the container 2 spaced from the internal surface of the housing 1. Asupport 5 is provided at the lower end of the housing 1 and has apassage 6 in which the valve stem 4 of the aerosol container 2 can belocated and supported. A second passage 7 is provided in the support 5and is directed towards the interior of the outlet 3. Thus, when theparts are in the positions shown in FIG. 1, the protruding portion ofthe aerosol container 2 can be depressed to move the container relativeto the valve stem 4 to open the valve and a dose of medicament containedin the aerosol will be discharged through the passage 7 and into theoutlet 3 from which it can be inhaled by a patient. One dose will bereleased from the aerosol container each time it is fully depressed.

FIG. 2 shows the lower part of a device similar to that of FIG. 1 butincorporating a dose indicating device according to the invention. Thedose indicating device comprises a body 8 firmly attached to the aerosolcontainer by means of tubular portion 9 formed with grips 10. Tubularportion 9 tightly engages the periphery of valve ferrule 11 while a gripin the form of lip 10 engages around neck 12 of valve ferrule 11 whichis formed during assembly when valve ferrule 11 is crimped onto aerosolcontainer 2. Thus the tubular portion 9 and lip 10 form a tightconnection to the aerosol container which once assembled by pushing thetubular portion 9 over the valve ferrule 11 cannot easily be dissembled.

Below tubular portion 9, body 8 forms a cradle 22 for mounting countermechanism 13 and drive pinion 14. Drive pinion 14 is friction mounted oncounter mechanism drive shaft 15. Drive pinion 14 is formed with anumber of teeth or pegs 21 which can engage with a number of recesses orgrooves formed on post 17 in the form of a rack moulded inside housing 1and extending from the base of the housing 1 parallel to valve stem 4.

As shown in FIGS. 3 and 4, drive shaft 15 is connected to driver yoke 16of counter mechanism 13. Driver yoke 16 has two switching latches 18 aand 18 b spaced either side of star wheel 19 such that driver yoke 16may tilt about the axis of drive shaft 15 between a first position shownin FIG. 4 b in which switching latch 18 a engages one side of star wheel19, and a second position shown in FIG. 4 d in which switching latch 18b engages the other side of star wheel 19. Star wheel 19 is connectedthrough a mechanism, similar to that described with reference toreference numerals 2 to 8 in FIGS. 1 to 3 of European Pat. No. 0280104,to three digit wheels 33, which have numbers printed on theircircumferential faces as described below. When located in the housing 1,counter mechanism 13 is small enough to be located to the sides of andbehind support 5 so as not to interfere with the aerosol flume as itemerges from passage 7.

The aerosol container 2 may be supplied to the patient with the doseindicating device ready assembled thereto. Alternatively, the housing 1may be supplied to the patient with the dose indicating device locatedin the position shown in FIG. 2 and the aerosol container 2 suppliedseparately. In this case, the patient is instructed to insert theaerosol container 2 into the housing 1 with the valve stem first. Uponfirst insertion of the container into the housing, the tubular portion 9and lip 10 of the dose indicating device ride over the periphery ofvalve ferrule 11 of the aerosol container 2 until lip 10 snaps aroundneck 12. Thereafter, the dose indicating device is attached to theaerosol container 2.

Other means of attachment of the dose indicator to the container areenvisaged including adhesive attachment; use of welded shrink sleeves;heat forming; crimping; ultrasonic welding; and by the presence of ano-ring elastomer on the container which is fixedly piercable by barbs onthe attachment member of the dose indicator.

To actuate the device, the protruding portion of the aerosol containeris depressed as described above with reference to FIG. 1. As the aerosolcontainer carrying the dose indicating mechanism moves within housing 1,drive pinion 14 starts to turn, through its engagement with post 17,causing rotation of drive shaft 15 and driver yoke 16. As driver yoke 16tilts with rotation of drive shaft 15 switching latch 18 a moves intoengagement with star wheel 19 (FIG. 4 a) causing an incrementalanti-clockwise rotation of a half tooth pitch of the star wheel untilthe switching latch 18 a can move no further in this direction, theswitching latch being positioned between two adjacent teeth of the starwheel (FIG. 4 b). At this point, drive shaft 15 cannot rotate anyfurther and any further movement of the aerosol container into housing 1results in drive pinion 14 continuing to rotate through its engagementwith post 17 by virtue of the friction coupling between pinion 14 anddrive shaft 15.

When the valve stem 4 has reached its fully depressed position and ametered dose of medicament has been discharged from the aerosolcontainer, the aerosol container is allowed to return to its originalposition. As the aerosol container and dose indicating mechanism returnto their original position, drive pinion 14 starts to rotate in theopposite direction together with drive shaft 15 and driver yoke 16.Thus, driver yoke 16 tilts such that switching latch 18 a moves out ofengagement with star wheel 19 while switching latch 18 b moves intoengagement therewith (FIG. 4 c), causing further incrementalanti-clockwise rotation of a half tooth pitch of the star wheel untilswitching latch 18 b can move no further in this direction (FIG. 4 d).Again, drive shaft 15 cannot rotate any further at this point and anyfurther movement of the aerosol container out of housing 1 results indrive pinion 14 continuing to rotate through its engagement with post 17by virtue of the friction coupling between pinion 14 and drive shaft 15.In this way it can be seen that the friction coupling acts as a lostmotion coupling which allows the dose indicating device to be used withaerosol containers having valves with different lengths of travel ofvalve stem during actuation.

Each time the aerosol dispenser is actuated the star wheel is made torotate through two incremental anti-clockwise movements as describedabove. These movements are translated through the counter mechanism intoappropriate movements of the digit wheels 33, one number on each of theprinted circumferential faces of the digit wheels being clearly visiblethrough the window 20 at the back of the housing 1 (as shown in FIG. 2),to indicate that a further dose of medicament has been dispensed. Byhaving three digit wheels 33 it is possible for the dose counter to beused to count hundreds of doses. Clearly if fewer than one hundred dosesare to be contained within the dispenser, the dose counter couldcomprise fewer digit wheels. Alternatively, if a thousand or more dosesare to be contained, then one or more additional digit wheels could beadded as appropriate.

To remove the aerosol container 2 from the housing for cleaning, theaerosol container 2 may be withdrawn from the housing 1 in the usualmanner. As the container is withdrawn, the friction coupling betweendrive pinion 14 and drive shaft 15 allows such further movement as isrequired for the drive pinion to come out of engagement with the post 17without causing any further indexing of the counter mechanism. Onceremoved, the housing 1 may be cleaned as described without fear ofinterfering with or damaging the dose indicating device, which remainsfirmly connected to the aerosol container 2.

When the housing 1 is clean, the aerosol container 2 with doseindicating device may be re-inserted into the housing 1. Duringinsertion, drive pinion 14 will engage post 17 and start to rotate untilthe aerosol container reaches its normal rest position with the valvestem 4 located in support 5. As the drive pinion 14 rotates, thefriction coupling will act as a lost motion mechanism as describedabove, allowing for any travel of the aerosol container as between firstengagement of drive pinion 14 and post 17, and location of valve stem 14in support 5. In this way, the friction coupling automaticallyaccommodates and compensates for different lengths of valve stemsprotruding from the ferrule, which would otherwise result in differentrelative start positions of the container relative to the indexingmechanism.

FIG. 5 shows an alternative lost motion coupling mechanism which may beused in an aerosol dispenser according to the invention. In thisembodiment, instead of a pinion, driver yoke 16 is formed with tworesilient arms 30 between which post 17 is grippingly engaged (FIG. 5a). Post 17 is formed with ribs on its surface (not shown) which providea rough surface finish to create the level of friction required betweenarms 30 and post 17 such that arms 30 will grip post 17 until the loadapplied overcomes the friction.

Upon actuation of the device, as the aerosol container and doseindicating mechanism move, the friction engagement between arms 30 andpost 17 cause driver yoke 16 to tilt about the axis of shaft 15 (notshown in FIG. 5), so moving switching latch 18 a into engagement withstar wheel 19 as discussed in relation to the first embodiment. Asswitching latch 18 a reaches its limit of travel, driver yoke 16 canmove no further, and any further movement of the aerosol container intohousing 1 results in arms 30 slipping down post 17 by virtue of thefriction coupling. Upon return to its original position, driver yoke 16tilts in the other direction until switching latch 18 b moves intoengagement with star wheel 19 and can move no further. Any furthermovement of the aerosol container out of housing 1 results in arms 30slipping up post 17.

FIGS. 6 to 9 show an inhalation device fitted with an electro-mechanicaldose indicating device according to the invention. As with themechanical embodiments discussed above, the dose indicating devicecomprises a body 40 firmly attached to the aerosol container by means oftubular portion 41 formed with grips (not shown). Tubular portion 41tightly engages the periphery of valve ferrule 11 while a grip in theform of a lip engages around neck 12 of valve ferrule 11. Thus thetubular portion 41 and lip form a tight connection to the aerosolcontainer which once assembled by pushing the tubular portion 41 overthe valve ferrule 11 cannot easily be disassembled.

Below tubular portion 41, body 40 forms a cradle for mounting countermechanism 43, and defines a chamber for accommodating switch slide 44.Switch slide 44 is a cylindrical washer made of silicone rubber andhaving a bore of such a diameter that, with the can and dose indicatingdevice mounted within the actuator housing, it provides a friction fiton pin 45, which is moulded in the housing and protrudes through a holein body 40. The friction fit of switch slide 44 on pin 45 ensures theswitch slide will not move along the pin unless pushed. Two contactmembers 46, 47, both of which comprise a switch contact and a circuitboard contact, and one of which further comprises a battery contact, aremounted such that the battery and circuit board contacts are in constantcontact with a first terminal of the battery 48 and printed circuitboard (PCB) 49 respectively. The switch contacts do not contact eachother but are positioned either side of pin 45, and define the upperlimit of movement of the switch slide 44 within its chamber. Thus, whenswitch slide 44 is in its upper position as shown in FIG. 9, it makescontact with both switch contacts, so closing the circuit between themdue to the electrical conductivity of the silicone rubber of the switchslide. Although in the embodiment described the switch slide is made ofsilicone rubber, it will be appreciated that it could alternatively bemade of a non-conductive rubber having an insert at its upper face madeof metal or some other conductive material.

In addition to its connections with contact members 46, 47, PCB 49 alsohas connections to the other terminal of the battery and to a threedigit liquid crystal display (LCD) 50 in a conventional manner. The PCBcomprises an application specific integrated circuit (ASIC), whichprovides the logic by which the dose indicator can be checked,programmed and made operational, as discussed in more detail below, tokeep a record of how many times the switch contact circuit is closed anddrives the LCD to display the number of doses remaining in the aerosolcontainer. The ASIC is thus designed and programmed accordingly in aknown manner.

Instead of a digital display, the LCD could alternatively be formattedto display an analogue indication. When the aerosol container is mountedin the actuator housing, LCD 50 is visible through window 20. In theembodiment depicted in FIG. 7, the LCD and window are located at theback of the housing, but they could equally be located at the front orsome other part of the housing.

The Counter mechanism 43 is small enough to be located to the sides ofand behind the stem block (support 5) moulded in housing so as not tointerfere with the aerosol flume as it emerges.

To actuate the device, the protruding portion of the aerosol containerwhen fitted into the actuator housing is depressed as described above.As the aerosol container carrying the dose indicating mechanism moveswithin the housing from its rest position (shown in FIG. 8), the chamberaccommodating switch slide 44 moves down until the upper face of switchslide 44, which is mounted on pin 45, meets switch contacts 46, 47 andthe switch circuit is closed. This causes the ASIC to decrement thenumber displayed by the LCD 50. As the aerosol container continues tomove, a metered dose of medicament is discharged from the valve, whileswitch slide 44 is pushed down along pin 45 by virtue of the frictionfit of the switch slide on the pin until the valve stem reaches itslimit of travel and the aerosol container moves no further (FIG. 9). Inthis way, it can be seen that the friction fit of the switch slide 44 onpin 45 allows for over-travel of the valve stem after the switch circuithas been closed, so acting as a lost motion coupling. The aerosolcontainer is then allowed to return to its original position within thehousing, and as it returns, the chamber accommodating switch slide 44moves up breaking the switch circuit as switch contacts 46, 47 move awayfrom switch slide 44. Body 40 then meets the lower face of switch slide44 and draws the switch slide up along pin 45 until the valve stemreturns to its rest position (FIG. 8).

Because the dose indicating device is designed to be suitable for use inconnection with different sized aerosol containers containing differentnumbers of doses to be delivered, the ASIC is designed to be factory setin accordance with the size of aerosol container with which the doseindicating device is assembled. After assembly of the dose indicatingdevice and first connection of the battery, the ASIC enters a self-testmode. After this, the programming mode may be entered by activating theswitch, allowing it to be programmed to count down from the appropriatenumber of doses (e.g. 200, 120, 80 or 60). This may be doneautomatically on a packing line. After programming has taken place, theASIC enters the counting mode, where the LCD decrements upon closing ofthe switch contact circuit. When the count of zero is reached, the ASICis designed to prevent the count from decrementing any further in aknown manner. In order to prevent spurious readings due to the effectsof switch ‘bounce’, the ASIC may be designed to decrement only after theswitch circuit has been closed for a predetermined length of time in aknown manner. In the event of the aerosol container getting jammed inthe actuated position after operation, or the switch circuit jammingclosed due to mechanical damage or contamination, the ASIC may bedesigned to blank the LCD to alert the user that there is a problem.

As with the other embodiments of the invention described above, theaerosol container may be withdrawn from the actuator housing in theusual manner. As the container is withdrawn, body 40 draws the switchslide up along pin 45 until it clears the pin altogether. Once removed,the housing may be cleaned without interfering with or damaging the doseindicating device, which remains firmly connected to the aerosolcontainer.

During re-insertion of the aerosol container, which can only occur whenthe body of the dose indicating device is correctly orientated withrespect to the housing by virtue of their respective shapes, switchslide 44 engages and is pushed up by pin 45 until the upper face meetsthe switch contacts. Further insertion of the aerosol container resultsin switch slide 44 being pushed down along pin 45 until the valve stemis seated back within support 5.

It will be appreciated that by programming of the ASIC, one design ofdose indicating device could be used in conjunction with a range ofaerosol containers of various capacities. By virtue of the switchmechanism, the same design of dose indicating device can also be used inconjunction with a range of different valves having different lengths ofvalve stem and different stem travel specifications.

Whilst the present invention has been described in detail in respect ofa metered dose inhaler actuatable manually by the patient it will beappreciated that other actuation mechanisms can be substituted. Inparticular, the use of a breath operated inhaler in which the actuationis assisted, and is responsive to, preferably triggered by, the inwardbreath of the patient, is also envisaged.

The dispenser of the invention is suitable for dispensing medicament,particularly for the treatment of respiratory disorders. Appropriatemedicaments may thus be selected from, for example, analgesics, e.g.,codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginalpreparations, e.g., diltiazem; antiallergics, e.g., cromoglycate,ketotifen or nedocromil; antiinfectives e.g., cephalosporins,penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti-inflammatories, e.g.,beclomethasone dipropionate, fluticasone propionate, flunisolide,budesonide, rofleponide, mometasone furoate or triamcinolone acetonide;antitussives, e.g., noscapine; bronchodilators, e.g., albuterol,salmeterol, ephedrine, adrenaline, fenoterol, formoterol, isoprenaline,metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol,reproterol, rimiterol, terbutaline, isoetharine, tulobuterol, or(−)-4-amino-3,5-dichloro-α-[[[6-[2-(2-pyridinyl)ethoxy]hexyl]methyl]benzenemethanol;diuretics, e.g., amiloride; anticholinergics, e.g., ipratropium,tiotropium, atropine or oxitropium; hormones, e.g., cortisone,hydrocortisone or prednisolone; xanthines, e.g., aminophylline, cholinetheophyllinate, lysine theophyllinate or theophylline; therapeuticproteins and peptides, e.g., insulin or glucagon. It will be clear to aperson skilled in the art that, where appropriate, the medicaments maybe used in the form of salts, (e.g., as alkali metal or amine salts oras acid addition salts) or as esters (e.g., lower alkyl esters) or assolvates (e.g., hydrates) to optimise the activity and/or stability ofthe medicament.

Preferred medicaments are selected from albuterol, salmeterol,fluticasone propionate and beclometasone dipropionate and salts orsolvates thereof, e.g., the sulphate of albuterol and the xinafoate ofsalmeterol.

Medicaments can also be delivered in combinations. Preferredformulations containing combinations of active ingredients containsalbutamol (e.g., as the free base or the sulphate salt) or salmeterol(e.g., as the xinafoate salt) in combination with an anti-inflammatorysteroid such as a beclomethasone ester (e.g., the dipropionate) or afluticasone ester (e.g., the propionate).

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the following claims:

1. A dispenser comprising: a housing; a container configured to containa medicament therein, said container having an outlet member configuredto dispense the medicament from the container, and an actuationindicator engaged to the container to form a unit therewith, wherein theunit is adapted in use to be reversibly located in the housing in anoperational position in which the unit is movable relative to thehousing to dispense the medicament from the outlet member; and whereinthe actuation indicator is wholly located in the housing in theoperational position.
 2. The dispenser according to claim 1, wherein theactuation indicator is engaged with the container in the vicinity of theoutlet member.
 3. The dispenser according to claim 1, wherein theactuation indicator is engaged with the outlet member.
 4. The dispenseraccording to claim 1, wherein the container is an aerosol container. 5.The dispenser according to claim 1, wherein the housing is provided withan outlet.
 6. The dispenser according to claim 5, wherein the outlet ispresent in the form of a mouthpiece.
 7. The dispenser according to claim5, comprising a passage through which dispensed doses pass when movingfrom the container to the outlet.
 8. The dispenser according to claim 1,wherein the container includes a metering valve adapted to dispensemetered doses.
 9. The dispenser according to claim 1, wherein theactuation indicator is fixed to the container by structure selected fromthe group consisting of an adhesive, a welded shrink sleeve, a heatform, a crimp, an ultrasonic weld, and an o-ring elastomer.
 10. Thedispenser according to claim 1, wherein the actuation indicator ispermanently fixed to the container.
 11. The dispenser according to claim1, wherein the actuation indicator comprises an indexing mechanismactuated by a predetermined movement of the container relative to thehousing.
 12. A dispenser comprising: a housing; a container configuredto contain a medicament therein having an outlet member configured todispense the medicament from the container, an actuation indicatorengaged to the container in the vicinity of the outlet member to form aunit therewith, wherein the unit is: reversibly locatable in thehousing, and movable relative to the housing to enable dispensing fromthe outlet member.
 13. The dispenser according to claim 12, wherein theactuation indicator is engaged with the outlet member.
 14. The dispenseraccording to claim 12, wherein the container is an aerosol container.15. The dispenser according to claim 12, wherein the housing is providedwith an outlet.
 16. The dispenser according to claim 15, wherein theoutlet is present in the form of a mouthpiece.
 17. The dispenseraccording to claim 15, comprising a passage through which dispenseddoses pass when moving from the container to the outlet.
 18. Thedispenser according to claim 12, wherein the container includes ametering valve adapted to dispense metered doses.
 19. The dispenseraccording to claim 12, wherein the actuation indicator is fixed to thecontainer by structure selected from the group consisting of anadhesive, a welded shrink sleeve, a heat form, a crimp, an ultrasonicweld, and an o-ring elastomer.
 20. The dispenser according to claim 12,wherein the actuation indicator is permanently fixed to the container.21. The dispenser according to claim 12, wherein said actuationindicator comprises an indexing mechanism actuated by a predeterminedmovement of said container relative to said housing.
 22. An assembly foruse in a medicament dispenser, said assembly comprising: a containerconfigured to house at least one medicament therein and having an outletmember configured to dispense the medicament from the container; and anactuation indicator assembled to the container to form a unit; whereinthe unit is adapted in use to be reversibly located in the medicamentdispenser in an operational position in which the actuation indicator iswholly located in the medicament dispenser and in which the container isable to be acted on by the dispenser to cause the outlet member todispense the medicament from the container.
 23. An actuation indicatorfor indicating dispensing from a container having an outlet end, theindicator having a body which is adapted to be mounted on the outlet endof the container so that the container and indicator form a unit that isreversibly removable from an actuator housing.
 24. The indicatoraccording to claim 23, wherein the body has a sleeve adapted to slideover the outlet end.
 25. The indicator according to claim 23, whereinthe outlet end has an outlet member configured to dispense a medicamentfrom the container, the outlet member protruding from the outlet end,and the body has a passageway adapted to slidingly receive the outletmember.
 26. The indicator according to claim 23, having an indexingmechanism in the body.
 27. The indicator according to claim 26, whereinthe indexing mechanism is a mechanical indexing mechanism.
 28. Theindicator according to claim 26, wherein the indexing mechanism has atleast one indicator wheel rotatably mounted in the body.
 29. Theindicator according to claim 28, wherein the at least one wheel isprovided with numerical indicia thereon.
 30. The indicator according toclaim 26, wherein the indexing mechanism has a member on which numericalindicia are provided.
 31. The indicator according to claim 23, having adose counting mechanism in the body.